How to validate a Dye Test method used to evaluate Package Integrity

M

mayrita01

Need help to know what to do to validate a dye test method. this test is used to evaluate package integrity of medical devices and other pmarma finish good. Any ideas, does any one have a Protocol to share.
Than:)ks
 
T

tamale

Maybe this will help,

Pira usually tests medical device packages for dye penetration in accordance with either ASTM F1929 or EN 868-1. ASTM F1929 is more applicable to porous material packaging such as Tyvek® pouches; whereas EN 868-1 is more suitable for non-porous materials including foils.


http://www.pira-international.com

Tamale
 
M

mayrita01

Thanks for your Reply. We are planning to use ASTM F1929. However I was thinking to perform a method verification for this test method. But dont exactly know what is enough. I have'nt take a look yet to the method, but we are thinking to do at least reproducibility/repeatability and accuracy. would that be enough? any ideas ...:)
 

v9991

Trusted Information Resource
considering that you have challenge-test (-ve samples) as a part of the package-integrity test; I think that said parameters might be enough;
now that was about the dye;

other parameters of method must also be considered viz., negative-pressure which is maintained during the test. which can also be considered to demonstrate robustness. (test carried out at different operational negative pressures)
 

Wolf.K

Quite Involved in Discussions
Hi,
I wonder if someone can give some hints about the number of tests to do to validate F1929?
 

Wolf.K

Quite Involved in Discussions
Well,

I am thinking about performing the test myself in our small lab. I have never officially validated a lab method. At the university, I never got training on validation (I think the professors there did not even know what validation is; they only bothered about the p value). If I calculate the number of tests with 95 % confidence interval and a reliability of 90%, I get a sample size of 30 tests, and at 95% reliability of 60 tests. So, for the validation of F 1929, I would have to perform the test about 60 times?
 
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